Validation Lead - Digitalization
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Are you an experienced validation lead? Are you passionate about quality assurance for digital solutions? Would you find it interesting to develop and define our best practices for validation of digital solutions and IT infrastructure, bringing your innovative spirit to our organization? Then you could be our new colleague - read more and apply!
The position
You will be validation lead on projects of varying sizes as well as helping and advising other projects on how to ensure that our digital solutions covering apps, dashboards, as well as machine learning tools are all in compliance.
Your daily tasks and responsibilities will be to:
• Lead compliance activities on projects as responsible for the end-to-end quality and compliance for our digital initiatives
• Work collaboratively across functions with stakeholders and vendors to plan, coordinate and execute IT system and infrastructure validation activities
• Perform risk-based validation of GxP systems and infrastructure to ensure requirements coverage and develop validation documents in accordance with corporate procedures
• Have the ownership for the development and delivery of complete validation packages
• Facilitate verification and validation activities including automated testing, documentation review and approval
You will be the interface between the ITQA organisation and our digital developers ensuring that we follow best practices for qualification and validation. You will also feedback learnings and suggestions on how to improve the validation process. Qualifications
For this positions, we are looking for someone that has worked with the guidelines provided by the global regulatory and authority agencies such as FDA, EMA and MHRA, in areas such as GxP, FDA 21CFR part 11 and GAMP Annex11.
To succeed in this role, you:
• have a Master’s degree in a relevant subject
• have some years of experience with IT validation in a GMP regulated environment
• have experience within pharmaceutical Quality Management, have taken part of GxP system and/or infrastructure qualification and validation
• are fully proficient in English
Also experience or interest within Azure DevOps, software development and scripted/automated testing is going to be considered an advantage. As a person, you are team-oriented, self-driven, proactive, and responsible. You are willing to bring your thoughts out in the open, creating a healthy discussion, and at the same time, setting a direction, giving and receiving feedback. You are looking forward to challenge the business processes by also collaborating closely with stakeholders, ready to operate in an environment that is subjected to frequent changes. About the department
In Novo Nordisk Digital Quality we are responsible for driving Innovation and Digital transformation across the Global Novo Nordisk Quality Organisation. We consist of a central team - that is responsible for strategy, follow up and support - and two departments: Process Digitalisation & Quality Data & Insights.
Process Digitalisation is responsible for making Digital Products that makes our Quality processes simpler and more effective. We have a tech stack that ranges from No-code/low-code to full stack. Quality Data & Insights are responsible for Data management of Quality owned data and providing valuable insights on Quality performance in an effective way to all levels in the organisation.
Our area is a group of engaged and highly skilled colleagues based at Novo Nordisk headquarters in Bagsværd, Denmark and our Global Service Center in India. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Lars Voigt +45 3075 8668, [email protected]
Deadline
29 January 2023
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
The position
You will be validation lead on projects of varying sizes as well as helping and advising other projects on how to ensure that our digital solutions covering apps, dashboards, as well as machine learning tools are all in compliance.
Your daily tasks and responsibilities will be to:
• Lead compliance activities on projects as responsible for the end-to-end quality and compliance for our digital initiatives
• Work collaboratively across functions with stakeholders and vendors to plan, coordinate and execute IT system and infrastructure validation activities
• Perform risk-based validation of GxP systems and infrastructure to ensure requirements coverage and develop validation documents in accordance with corporate procedures
• Have the ownership for the development and delivery of complete validation packages
• Facilitate verification and validation activities including automated testing, documentation review and approval
You will be the interface between the ITQA organisation and our digital developers ensuring that we follow best practices for qualification and validation. You will also feedback learnings and suggestions on how to improve the validation process. Qualifications
For this positions, we are looking for someone that has worked with the guidelines provided by the global regulatory and authority agencies such as FDA, EMA and MHRA, in areas such as GxP, FDA 21CFR part 11 and GAMP Annex11.
To succeed in this role, you:
• have a Master’s degree in a relevant subject
• have some years of experience with IT validation in a GMP regulated environment
• have experience within pharmaceutical Quality Management, have taken part of GxP system and/or infrastructure qualification and validation
• are fully proficient in English
Also experience or interest within Azure DevOps, software development and scripted/automated testing is going to be considered an advantage. As a person, you are team-oriented, self-driven, proactive, and responsible. You are willing to bring your thoughts out in the open, creating a healthy discussion, and at the same time, setting a direction, giving and receiving feedback. You are looking forward to challenge the business processes by also collaborating closely with stakeholders, ready to operate in an environment that is subjected to frequent changes. About the department
In Novo Nordisk Digital Quality we are responsible for driving Innovation and Digital transformation across the Global Novo Nordisk Quality Organisation. We consist of a central team - that is responsible for strategy, follow up and support - and two departments: Process Digitalisation & Quality Data & Insights.
Process Digitalisation is responsible for making Digital Products that makes our Quality processes simpler and more effective. We have a tech stack that ranges from No-code/low-code to full stack. Quality Data & Insights are responsible for Data management of Quality owned data and providing valuable insights on Quality performance in an effective way to all levels in the organisation.
Our area is a group of engaged and highly skilled colleagues based at Novo Nordisk headquarters in Bagsværd, Denmark and our Global Service Center in India. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Lars Voigt +45 3075 8668, [email protected]
Deadline
29 January 2023
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 12.1.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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